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The Effect of Exercise on Blood Glucose Levels in Patients With Type 1 Diabetes: A Comparison of 3 Long-acting Insulins

An Assessment of the Impact of Performing Physical Exercise on the Maximum Plasma Glucose Decline in Subjects With Type 1 Diabetes Managed on a Basal Bolus Insulin Regimen: A Comparison of 3 Basal Insulin Treatments - Insulin Detemir, Insulin Glargine and NPH Insulin

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00313742
Enrollment
51
Registered
2006-04-12
Start date
2006-04-30
Completion date
2006-11-30
Last updated
2023-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief summary

This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.

Interventions

DRUGinsulin detemir
DRUGinsulin glargine
DRUGinsulin NPH

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Type 1 Diabetes * Current basal-bolus insulin therapy * HbA1c \< 10% * BMI \< 32 kg/m2

Exclusion criteria

* Proliferative Retinopathy / Maculopathy * Recurrent major hypoglycaemias * Impaired hepatic or renal function * Cardiac Problems * Uncontrolled hypertension

Design outcomes

Primary

MeasureTime frame
The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercisefollowing 4 weeks of treatment

Secondary

MeasureTime frame
Plasma glucose pre-exercise & post-exercise—
Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning—
Plasma glucose profile post-exercise—
Incidence of adverse events during the trial—

Countries

Germany, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026